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Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers (NIRS-OSAS)
This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), February 2009
First Received: December 21, 2007   Last Updated: February 5, 2009   History of Changes
Sponsors and Collaborators: ISS, Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Carle Foundation Hospital
University of Illinois
University of California, Irvine
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00591591
  Purpose

The goal of this trial is to assess the performance of the OxiplexTS—an absolute near-infrared oximeter—as an instrument to measure brain oxygenation and hemodynamics in sleep medicine as well as in the broader field of cardiovascular/cerebrovascular diagnostics.


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
Device: OxiplexTS
Phase III

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Parallel Assignment
Official Title: Absolute Near-Infrared Brain Oximeter

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Absolute brain oximetry: Quantitative hemodynamic responses of brain during sleep, in healthy & OSA subjects. OxiplexTS will determine % of cerebral oxygenation and absolute oxy, deoxy & total hemoglobin concentrations in brain tissue during sleep. [ Time Frame: 6 hours of sleep ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Apnea Hyperpnoea Index (AHI) determined during the routine sleep study. [ Time Frame: 6 hours of sleep ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
OSA: Experimental
Persons with obstructive sleep apnea
Device: OxiplexTS

OxiplexTS is a Frequency Domain Neat-Infrared Tissue oximeter which provides absolute values of tissue oxygen saturation in real time. The instrument also provides other important physiological quantities such as total hemoglobin concentration and the individual concentration of oxy- and deoxy-hemoglobin, which form the basis for the functional relevant measurement for brain hemodynamics.

Both the control and OSA groups will undergo standard overnight sleep study (polysomnography). In addition to the standard PSG (with or without Continuous Positive Airway Pressure (CPAP)), the study researchers will add the OxiplexTS, allowing them to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to those of the persons with OSA. Participants with OSA who undergo PSG/CPAP will be tested with the OxiplexTS as well. Their PSGs and PSG/CPAP data will be compared.

Controls: No Intervention
Healthy controls

Detailed Description:

Frequency domain near-infrared spectroscopy (NIRS) offers the advantage of performing safe, non-invasive, transcranial, quantitative measurements of brain oxygenation and hemodynamics in real-time. These characteristics make NIRS the ideal tool to study physiological and pathological processes of the brain, in settings ranging from research and diagnostic laboratories to intensive care units and operating rooms.

Scientists recently developed the first commercially available absolute near-infrared oximeter, called OxiplexTS. This portable device will be used to study brain vascular autoregulatory responses (such as responses to hypoxia and hypercapnia) in persons with obstructive sleep apnea (OSA). These responses to allow for the assessment of brain vascular health. The OxiplexTS device will be beneficial in identifying persons at risk for cerebrovascular disease. Polysomnography (PSG), which is currently used to assess sleep disorders, gives important information on the function of different systems, however, it does not provide information on brain oxygenation and hemodynamics during sleep. The assessment of these factors, via NIRS, in persons with OSA is crucial because of the high prevalence of the disorder and the significant cardio/cerebrovascular health risk it represents.

The specific aim of this trial is to make OxiplexTS a clinically usable instrument, especially for research and clinical diagnosis and monitoring of sleep disorders. An additional goal is to determine the usefulness of this instrument for providing measurements in various clinical situations including intensive care management or prolonged surgical procedures, such as cardiothoracic surgery that require critical information of brain oxygenation and hemodynamics. This trial emerges from previous phase I and phase II studies which determined the feasibility of using OxiplexTS to assess brain vascular autoregulatory responses to hypoxic stimuli.

Approximately 300 participants will be recruited from a pool of healthy individuals, individuals with OSA, and volunteers undergoing overnight diagnostic or therapeutic PSG for suspected OSA.

Participants will be divided into two groups: healthy controls and persons with OSA. Both groups will undergo standard overnight sleep study or PSG.

In addition to the standard PSG (with or without Continuous Positive Airway Pressure (CPAP)), the study researchers will add the OxiplexTS—allowing them to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to those of persons with OSA. Participants with OSA who undergo PSG/CPAP will be tested with the OxiplexTS, as well. Their PSG and PSG/CPAP data will be compared.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals (controls)
  • Individuals undergoing overnight polysomnography foe suspected obstructive sleep apnea

Exclusion Criteria:

  • Documented severe cardiovascular disease.
  • Documented cerebrovascular disease
  • Documented cardiopulmonary disease
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591591

Contacts
Contact: Antonios Michalos, M.D., M.S. 217-359-8681 antonios.michalos@iss.com

Locations
United States, California
University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23 Recruiting
Orange, California, United States, 92868
Contact: Marcel Hungs, MD, PhD     714-456-5105     mhungs@uci.edu    
Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road Not yet recruiting
Stanford, California, United States, 94305
Contact: Christian Guilleminault, MD     650-723-6601     cguil@leland.stanford.edu    
United States, Illinois
Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison Recruiting
Chicago, Illinois, United States, 60612
Contact: Christopher O. Olopade, MD, MPH     312-996-8039     cosolopa@uic.edu    
Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street Recruiting
Urbana, Illinois, United States, 61801
Contact: Daniel L. Picchietti, MD     217-383-9138     Daniel.Picchietti@carle.com    
Sponsors and Collaborators
ISS, Inc.
Carle Foundation Hospital
University of Illinois
University of California, Irvine
Investigators
Principal Investigator: Antonios Michalos, M.D., M.S. ISS, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: ISS, Inc. ( Antonios Michalos, M.D., M.S./Director of Medical Research, Principal Investigator )
Study ID Numbers: R44NS040597, 2R44NS040597-04, GRANT00130523, RNS040597C
Study First Received: December 21, 2007
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00591591     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Obstructive Sleep Apnea Syndrome
sleep disordered breathing
polysomnography (psg)
continuous positive airway pressure (cpap)
brain vascular autoregulation
brain tissue oxygenation
near-infrared spectroscopy
Obstructive Sleep Apnea

Study placed in the following topic categories:
Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Disease
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on May 07, 2009